
Own and support designated MR product manufacturing processes and Device Master Records (DMR).
Partner with cross-functional teams to drive product quality, manufacturability, and productivity improvements.
Develop, validate, and maintain manufacturing processes, assembly line tooling, jigs, fixtures, and test equipment.
Lead process validation activities and ensure manufacturing readiness for production requirements.
Drive manufacturing quality improvements through defect reduction initiatives and process optimization.
Perform root cause analysis and implement corrective and preventive actions (CAPA) for manufacturing and product-related issues.
Manage process risk assessments including Process Failure Mode and Effects Analysis (pFMEA).
Support Engineering Change Requests (ECRs) and ensure effective implementation of engineering changes within manufacturing operations.
Monitor and improve key manufacturing quality metrics including nonconformances, defect rates, and CAPA effectiveness.
Drive Lean Manufacturing, digitization, automation, and plant modernization initiatives to improve operational efficiency.
Ensure compliance with applicable Quality Management System (QMS) requirements and medical device manufacturing standards.
Prepare and maintain technical documentation, validation records, process instructions, and engineering reports.
Collaborate with production teams to resolve manufacturing challenges and support continuous improvement activities.
Bachelor’s or Master’s degree in Electrical Engineering, Electronics Engineering, Electronics & Communication Engineering, Biomedical Engineering, Medical Electronics, Mechanical Engineering, Production Engineering, or related discipline.
2+ years of experience in manufacturing engineering, production engineering, or related engineering functions.
Strong understanding of Manufacturing processes and industrial engineering principles.
Hands-on experience with problem-solving methodologies, root cause analysis, and continuous improvement tools.
Working knowledge of Lean Manufacturing and Six Sigma concepts.
Understanding of Quality Management Systems (QMS) and quality assurance practices.
Strong technical documentation and reporting skills.
Effective verbal and written communication skills.
Ability to manage multiple priorities and deliver results with quality and timeliness.
Strong teamwork and interpersonal skills.
Experience within the medical device, healthcare technology, or regulated manufacturing industry.
Exposure to MR, imaging systems, or complex electromechanical products.
Knowledge of medical device quality and regulatory requirements.
Lean Six Sigma Green Belt certification or equivalent continuous improvement training.
Experience supporting product lifecycle management and engineering change processes.
Exposure to product development, manufacturing transfer, or cross-functional engineering projects.
Strong analytical and >
Relocation Assistance Provided: No